Integrated device for analyte, testing, confirmation, and donor identity verification

ABSTRACT

The present invention provides an apparatus for fluid sample collection and analyte testing, including a sample receiving member and at least one membrane test strip, and optionally a sample retention member, fingerprint acquisition pad, and/or fluid collector. It also provides a fluid collection apparatus having an absorbent material, compression element, and closure element, and optionally a lid that allows the apparatus to be used in conjunction with a fluid container. Also provided are methods of collecting, testing, and retaining a fluid sample and verifying the identity of one or more individuals associated with the sample, such as the test subject, test administrator, and/or witnesses.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of Ser. No. 11/394,189, filedMar. 31, 2006, which is now pending, and which is hereby incorporated byreference in its entirety.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates to substance collection and testing. Moreparticularly, the present invention relates to a device that tests afluid sample for the presence or absence of at least one analyte,optionally secures the fluid sample for later confirmation, andoptionally provides positive identification of an individual associatedwith the sample. In another aspect, the present invention relates to adevice for collecting a fluid sample.

2. Background

Drug and other analyte testing has become ubiquitous in modern society.In homes, doctors' offices, law enforcement, athletics, and theworkplace, effective, inexpensive and reliable testing devices have beensought. There is also a growing need for devices to test bodily fluidsfor substances that may assist in the diagnosis or management ofdiseases and other medical conditions.

The marketplace has responded and is replete with many devices directedto the testing of blood, urine or saliva. However, these devices mayrequire a series of tests involving the shifting of the fluid samplebeing tested to different containers and/or the removal of the fluidsample to distant locations. These devices may also require the testadministrator to handle the test subject's bodily fluids, incurring adanger of disease exposure.

Once an initial test result has been obtained, further testing of thefluid sample to confirm or refine the initial test result is oftenrequired. For a membrane test strip device, the fluid sample may noteven be retained once the initial result is obtained, necessitatingretention of a separate sample. The need to retain a separate sampleincurs the risk that a sample could be lost, mislabeled, orcontaminated.

Oftentimes, the chain of custody associated with a test sample imbuesthe results with doubt, as the fluid sample may become contaminated,misplaced or a different fluid sample may be substituted entirely. Inmany instances, identification of the test subject associated with thefluid sample is critically dispositive.

There is also a growing need for devices directed to testing forcontaminants that may be found in food or water, such as pollutants,allergens, and harmful microbes. In some instances it may be desirableto retain a fluid sample for confirmation testing or further analysis,or to provide positive identification of the test administrator.

These goals are practically impossible to achieve using current devicesand methods. Thus, a need exists in the industry to combine thesimplicity of current membrane test strip technology with the ability topositively identify the test subject and/or the test administrator, aswell as the capability to secure the fluid sample for laterconfirmation, within a single device.

BRIEF SUMMARY OF THE INVENTION

According to an embodiment, the present invention provides an apparatuscomprising: a sample receiving member, to receive a fluid sample; asample retention member, in fluid communication with the samplereceiving member, to retain a portion of the fluid sample; and at leastone membrane test strip, in fluid communication with the samplereceiving member, to indicate the presence or absence of at least oneanalyte in the fluid sample.

According to another embodiment, the invention provides an apparatus,comprising: a sample receiving member, having an opening to receive afluid sample; a fluid collector to collect the fluid sample and conveythe fluid sample into the sample receiving member; at least one membranetest strip, in fluid communication with the sample receiving member, toindicate the presence or absence of at least one analyte in the fluidsample, and a fingerprint acquisition pad.

According to a further embodiment, the present invention provides afluid collector comprising: an absorbent material, to absorb a fluidsample; a compression member operatively associated with the absorbentmaterial; and a closure member, capable of sealing the open end of asample receiving member when the fluid collector is inserted in thesample receiving member.

According to a still further embodiment, the present invention providesan apparatus comprising: a fluid collector to collect the fluid sampleand convey the fluid sample into the sample receiving member,comprising: an absorbent material, to absorb the fluid sample; acompression member operatively associated with the absorbent material;and a closure member, capable of sealing the open end of the samplereceiving member when the fluid collector is inserted in the samplereceiving member; a sample receiving member, having an opening toreceive a fluid sample; a sample retention member, in fluidcommunication with the sample receiving member, to retain a portion ofthe fluid sample; at least one membrane test strip, in fluidcommunication with the sample receiving member, to indicate the presenceor absence of at least one analyte in the fluid sample; and afingerprint acquisition pad.

According to a still further embodiment, the present invention providesa method of testing a fluid sample, comprising: collecting a fluidsample in an absorbent material; conveying the absorbent material into areceiving member of an apparatus; compressing the absorbent material,whereby: the fluid sample is expelled from the absorbent material intochannels within the apparatus; the fluid sample encounters at least onemembrane test strip within the apparatus that visually indicates thepresence or absence of each of one or more analytes; a portion of thefluid sample is retained in a sample retention member of the apparatus;contacting the finger of an individual associated the test with afingerprint acquisition pad operatively associated with the apparatus,whereby a fingerprint is collected.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

The above and other advantages of this invention will become moreapparent by the following description of invention and the accompanyingdrawings.

FIG. 1 depicts a front view of a fluid collection and analyte testingdevice in accordance with an embodiment of the present invention.

FIG. 2 depicts a top view of a fluid collection and analyte testingdevice in accordance with an embodiment of the present invention.

FIG. 3 depicts a back view of a fluid collection and analyte testingdevice in accordance with an embodiment of the present invention.

FIG. 4 depicts a two perspective views of a fluid collector inaccordance with an embodiment of the present invention.

FIG. 5 depicts a front view of a fluid collection and analyte testingdevice in accordance with an embodiment of the present invention.

FIG. 6 depicts a front view of a fluid collection and analyte testingdevice in accordance with an embodiment of the present invention.

FIG. 7 depicts a front cutaway view of a fluid collection and analytetesting device in accordance with an embodiment of the presentinvention.

FIG. 8 depicts a back view of a fluid collection and analyte testingdevice in accordance with an embodiment of the present invention.

FIG. 9 depicts a back view of a fluid collection and analyte testingdevice in accordance with an embodiment of the present invention.

FIG. 10 depicts an isometric view of a fluid collection and analytetesting device in accordance with an embodiment of the presentinvention, in which a fluid collector rests in its holder in an analytetesting device.

FIG. 11 depicts an isometric view of a fluid collection and analytetesting device in accordance with an embodiment of the presentinvention, in which a fluid collector is being inserted into an analytetesting device.

FIG. 12 depicts a front cross-sectional view of a fluid collection andanalyte testing device in accordance with an embodiment of the presentinvention.

FIG. 13 depicts an isometric cross-sectional view of a fluid collectionand analyte testing device in accordance with an embodiment of thepresent invention.

FIG. 14 depicts a rear view of a fluid collection and analyte testingdevice in accordance with an embodiment of the present invention.

FIG. 15 depicts a rear view of a fluid collection and analyte testingdevice in accordance with an embodiment of the present invention havingthe rear door and fingerprint removed to show a fluid channel beneath.

FIG. 16 depicts a front view and a cross-sectional front view of a fluidcollection device in accordance with an embodiment of the presentinvention.

FIG. 17 depicts a cross-sectional front view of a urine cup inaccordance with an embodiment of the present invention.

FIG. 18 depicts a cross-sectional front view of a urine cup with a fluidcollector inserted therein in accordance with an embodiment of thepresent invention.

DETAILED DESCRIPTION OF THE INVENTION

Analyte Screening

An embodiment of the present invention provides an analyte screeningdevice which includes a rapid screening, lateral flow chromatographicimmunoassay for the simultaneous, qualitative or quantitative detectionof analytes in a fluid sample. For example, without limitation, thefluid sample may be saliva, urine, blood, mucus, water, or fluid extractof a solid or a semi-solid, for example stool or mucus. The fluid samplemay also be an environmental sample, for example, without limitation,soil, dust, water, plant matter, insect, animal matter, or a fluidextract of any of the foregoing. The fluid sample may also be a food orbeverage, for example, without limitation, a liquid beverage, aliquid-containing food, or a fluid extract of a solid, semi-solid orpowdered food or beverage.

An embodiment of the invention includes at least one membrane teststrip, in fluid communication with a sample receiving member, able toindicate the presence or absence of at least one analyte above or belowa threshold concentration in the fluid sample using a lateral flowchromatographic assay.

In an embodiment of the invention, the lateral flow chromatographicassay is a competitive assay, in which an analyte in the fluid samplecompetes with a competitor for binding with an anti-analyte antibody.For example, the anti-analyte antibody may be labeled, and thecompetitor may be immobilized in the test region of the membrane teststrip. After the fluid sample reaches the dye region, it encounters thelabeled anti-analyte antibody. If the analyte is present in the fluidsample above a predetermined threshold concentration, the analyte willsaturate the binding sites of the labeled anti-analyte antibody;otherwise, some or all of the labeled anti-analyte antibody remains freeto bind the competitor. As the fluid sample migrates along the membranetest strip by capillary action, it carries the labeled anti-analyteantibody along until it reaches the test region. The test regioncontains the immobilized competitor, which may be the analyte, fragmentsof the analyte, epitopes of the analyte, molecular mimics of theanalyte, anti-idiotypic antibodies, or any other molecule able tocompete with the analyte for binding to the anti-analyte antibody. Ifthe analyte is present above the predetermined threshold concentration,the labeled anti-analyte antibody is saturated and does not bind theimmobilized competitor, resulting in no signal in the test region;otherwise, the anti-analyte antibody is unsaturated and can bind to thecompetitor, resulting in a signal in the test region.

Thus, according to an embodiment of the invention employing acompetitive assay, an analyte-negative fluid sample (containing lowerthan the predetermined concentration of the analyte) will generate aline in the test region due to capture of the labeled anti-analyteantibody, whereas an analyte-positive fluid specimen will not generate acolored line in the test region because the analyte in the fluid samplewill saturate the labeled antibody and thus prevent its capture in thetest region.

In an embodiment of the invention, the lateral flow chromatographicassay is a sandwich assay, in which the analyte must be present for thelabeled anti-analyte antibodies to be captured in the test region. Forexample, the anti-analyte antibody may be a labeled antibody, and asecond anti-analyte antibody may be immobilized in the test region. Forexample, after the fluid sample reaches the dye region, it encountersthe labeled anti-analyte antibody. If the analyte is present in thefluid sample, it will bind at least a fraction of the labeledanti-analyte antibody. As the fluid sample migrates along the membranetest strip by capillary action, it carries the labeled anti-analyteantibody along until it reaches the test region. The test regioncontains an immobilized anti-analyte antibody, which may be reactiveagainst a different epitope of the analyte than the labeled anti-analyteantibody. If the analyte is present in the fluid sample, it forms ascaffold through which the labeled antibodies are immobilized in thetest region. The fraction of the labeled antibodies captured in the testregion is thus determined by the concentration of analyte in the fluidsample. If the analyte of interest is present above a predeterminedthreshold concentration, a sufficient fraction of the labeled antibodiesare captured, resulting in a visible signal in the test region;otherwise, an insufficient fraction of the antibodies are captured andno signal is visible in the test region.

Thus, according to an embodiment of the invention employing a sandwichassay, an analyte-positive fluid specimen will generate a colored linein the test region of the membrane test strip due to the capture of thelabeled antibody in the test region, whereas an analyte-negative fluidsample will not generate a line in the test region due to failure tocapture the labeled antibody.

Embodiments of the invention include a positive control to indicate thatthe assay has functioned properly and is complete. For example, the dyeregion may include a labeled control protein, including withoutlimitation a labeled control antibody, and the control region of themembrane test strip may contain an immobilized control agent able tocapture the labeled control protein, such as an antibody or a controlanalyte. The control region may be located distal to each test region onthe membrane test strip, such that the fluid sample will encounter eachtest region before encountering the control region. The reaction of thelabeled control protein with the immobilized control agent produces acolored line in the control region, indicating that a proper volume ofthe fluid sample has been added and membrane wicking has occurred, andthe assay has worked properly.

An embodiment of the invention concurrently tests for multiple analytes,for example by employing membrane test strips capable of testingmultiple analytes concurrently (for example, by containing multipleanti-analyte antibodies in the dye region and having multiple compatibletest region), and/or by employing multiple membrane test strips withinthe same apparatus. An embodiment of the invention includes bothmembrane test strips that employ a competitive assay and a sandwichassay, for example on different membrane test strips within the deviceand/or on the same membrane test strip within the device.

Embodiments of the invention may provide quantitative determination ofthe concentration of an analyte that is present in the fluid sample. Forexample, the apparatus may include multiple membrane test strips havingvarying amounts of an anti-analyte antibody, resulting in varyinganalyte sensitivity, such that the concentration of the analyte isindicated by which of the membrane test strips show or fail to show acolored line in the test region.

Antibodies

An embodiment of the invention employs antibodies for the detection ofanalytes. The term “antibody” (Ab) as used herein includes monoclonalantibodies, polyclonal antibodies, multispecific antibodies (for examplebispecific antibodies), and antibody fragments, so long as they exhibitthe desired activity. The term “monoclonal antibody” as used hereinrefers to an antibody obtained from a population of substantiallyhomogeneous antibodies, that is, the individual antibodies comprisingthe population are identical except for possible naturally-occurringmutations that may be present in minor amounts.

The terms “labeled antibody” and “labeled control protein” refer to anantibody or protein that is conjugated directly or indirectly to alabel. The label is a detectable compound or composition that may bedetectable by itself, including without limitation a dye, colloidalmetal (including without limitation colloidal gold), radioisotope, orfluorescent compound, or, in the case of an enzymatic label, maycatalyze chemical alteration of a substrate compound or compositionwhich is detectable, or any combination of the foregoing.

Analytes

According to an embodiment of the invention, the apparatus includes adevice for testing a fluid sample for the presence of analytes. Thepresent invention contemplates testing for any analyte. Withoutlimitation, analytes that may be tested for include drugs of abuse ortheir metabolites, analytes indicating the presence of an infectiousagent or product of an infectious agent, allergen, pollutant, toxin,contaminant, analyte with diagnostic or medical value, antibody againstany of the foregoing, and any combination thereof.

According to an embodiment of the invention, analytes that may be testedfor include drugs of abuse and their metabolites, including withoutlimitation 7-acetaminoclonazepam, alkyl nitrites,alpha-hydroxyalprazolam, alprazolam,2-amino-2′-chloro-5-nitrobenzophenone, 7-aminoclonazepam, 7-aminonitrazepam, amitriptyline, amobarbital, amoxapine, amphetamine, anabolidsteroids, androgen, androstadienone, aprobarbital, atropine,barbiturates, benzodiazepines, benzoylecgonine, benzylpiperazine,boldenone undecylenate, 4-bromo-2,5-dimethoxyphenethylamine, bovinegrowth hormone, butabarbital, butalbital, butriptyline,4-chlordehydromethyltestosterone, chloroform, clomipramine, clonazepam,clostebol, cocaethylene, cocaine, codeine, codeine-6-glucuronide,cotinine, dehydroepiandrosterone, desipramine, desmethyldiazepam,desoxymethyltestosterone, dexmethylphenidate, dextroamphetamine,dextromethorphan, dextropropoxyphene, dextrorphan,2,5-diamino-2′-chlorobenzophenone, diamorphine, diazepam, dibenzepin,dihydrotestosterone, dimenhydrinate,2,5-dimethoxy-4-(n)-propylthiophenethylamine,2,5-dimethoxy-4-ethylphenethylamine, 2,5-dimethoxy-4-iodophenethylamine,dimethyl ether, dimethyltryptamine, dimethyltryptamine, diphenhydraminehydrochloride, dosulepin hydrochloride, dothiepin hydrochloride,doxepin, drostanolone, ecgonine, ecgonine methyl ester, ephedrine,ergine, estren, 5-estrogen,ethyl-5-(1′-methyl-3′-carboxypropyl)-2-thiobarbituric acid,5-ethyl-5-(1′-methyl-3′-hydroxybutyl)-2-thiobarbituric acid,ethylestrenol, ethylphenidate, fentanyl, flunitrazepam, fluoxymesterone,furazabol, gamma-hydroxybutyrate, 1-(beta-D-glucopyranosyl) amobarbital,growth hormone, heroine, hexobarbital, human chorionic gonadotropin,human growth hormone, hydrocodone, hydromorphone,(+)-3-hydroxy-N-methylmorphinan, 3-hydroxy clonazepam,11-hydroxy-tetrahydrocannabinol (11-hydroxy-THC), 3′-hydroxyamobarbital,p-hydroxyamphetamine, p-hydroxynorephedrine, imipramine, iprindole,kava, ketamine, levomethylphenidate, lofepramine, lorazepam,lorazepam-glucuronide, lysergic acid diethylamide, meperidine,mescaline, mestanolone, mesterolone, meta-chlorophenylpiperazine,methadone, methamphetamine, methandrostenolone, methcathinone,3,4-methylenedioxyamphetamine, methenolone, methenolone enanthate,methylenedioxymethamphetamine (ecstacy), methylphenidate,methylphenobarbital, methyl testosterone, mibolerone, (+)-3-morphinan,morphine, nandrolone, nicotine, nitrazepam, N-methyl-diethanolamine,norbolethone, norcodeine, norethandrolone, norketamine, nortriptyline,opiates, opipramol, opium, oxabolone cipionate, oxandrolone, oxazepam,oxycodone, oxymetholone, oxymorphone, pentobarbital, phencyclidine,phenethylamines, phenobarbital, 4-phenyl-4-(1-piperidinyl)-cyclohexanol,1-phenyl-1-cyclohexene, phenylacetone,5-[N-(1-phenylcyclohexyl)]-aminopentanoic acid,1-(1-phenylcyclohexyl)-4-hydroxypiperidine, piperidine, protriptyline,psilocin, psilocybin, quinbolone, salvinorin A, scopolamine,secobarbital, sodium thiopental, stanozolol, talbutal, temazepam,testosterone, testosterone propionate, tetrahydrocannabinol (THC),THC-COOH, tetrahydrogestrinone, toluene, trenbolone, tricyclicantidepressant, 3-trifluoromethylphenylpiperazine, trimipramine,tryptamines, or any combination thereof. The minimum concentration levelat which the presence of any particular drug or metabolite is detectedmay be determined by various industry minimum standards, such as, forexample, the National Institute on Drug Abuse (NIDA), the SubstanceAbuse & Mental Health Services Administration (SAMHSA), and the WorldHealth Organization (WHO).

According to an embodiment of the invention, analytes that may be testedfor include infectious agents or the products of an infectious agent,including without limitation Acanthamoeba, aflatoxin, alimentarymycotoxicoses, altertoxin, amoeba, Anisakis, Ascaris lumbricoides,Bacillus anthracis, Bacillus cereus or its toxin, bacteria, bovinespongiform encephalopathy prions, Brucella, Caliciviridae,Calymmatobacterium granulomatis, Campylobacter, Campylobacter jejuni,Candida, Candida albicans, Cephalosporium, Chlamydia trachomatis,chronic wasting disease prions, Citrinin, Clostridium botulinum or itstoxin, Clostridium perfringens, Corynebacterium ulcerans, Coxiellaburnetii, Creutzfeldt-Jakob disease prions, Cryptococcus neoformans,Cryptosporidium, Cryptosporidium parvum, Cyclopiazonic acid, Cyclosporacayetanensis, Cytochalasin, Cytomegalovirus, Diphyllobothrium,Escherichia Coli, Ebola, endotoxin, Entamoeba histolytica, Enterovirus,Ergopeptine alkaloid, Ergot alkaloid, Ergotamine, Escherichia coli O157,Eustrongylides, Fasciola hepatica, fatal familial insomnia prions,flatworm, Francisella tularensis, Fumitremorgen B, Fumonisin, Fusarium,Fusarochromanone, genital warts, Gerstmann-Sträussler-Scheinker syndromeprions, Giardia, Giardia lamblia, Granuloma inguinale, H7enterohemorrhagic, Haemophilus ducreyi, Helicobacter pylori, Hepatitis,Hepatitis A, Hepatitis B, Hepatitis C, Hepatitis D, Hepatitis E,Hepatitis E, herpes simplex virus, Histoplasma capsulatum, HIV, HIV-1,HIV-2, human papillomavirus, influenza, Kaposi's sarcoma-associatedherpesvirus, Kojic acid, kuru prions, Listeria monocytogenes, Lolitremalkaloids, marburg virus, Methicillin-resistant Staphylococcus aureus orits toxin, molluscum, Moniliformin, mononucleosis, mycobacteria,Mycobacterium tuberculosis, Mycoplasma, Mycoplasma hominis, Mycotoxins,Myrothecium, Nanophyetus, Neisseria gonorrhoeae, nematode, Nivalenol,Norovirus, Ochratoxins, Oosporeine, parasites, Patulin, Paxilline,Penitrem A, Phomopsins, Plasmodium, Platyhelminthes, Plesiomonasshigelloides, Pneumococcus, Pneumocystis jirovecii, prions, protozoa,rhinovirus, Rotavirus, Salmonella, Sarcocystis hominis, Sarcocystissuihominis, scrapie prions, sexually transmitted disease, Shigella,Shigella, Sporidesmin A, Stachybotrys, Staphylococcus aureus or itstoxin, Sterigmatocystin, Streptococcus, Streptococcus pneumoniae,Streptococcus pyogenes, Taenia saginata, Taenia solium, tapeworm, Teniasolium, Tinea, Toxoplasma gondii, Tremorgenic mycotoxins, Treponemapallidum, Trichinella spiralis, Trichoderma, Trichomonas vaginalis,Trichothecene, Trichuris trichiura, Trypanosoma cruzi, Ureaplasmaurealyticum, Verrucosidin, Verruculogen, Vibrio cholerae non-O1, Vibriocholerae O1, Vibrio parahaemolyticus, Vibrio vulnificus, viruses, yeastinfections, Yersinia enterocolitica, Yersinia pseudotuberculosis,Zearalenols, Zearalenone, antibodies against any of the foregoing, orany combination thereof.

According to an embodiment of the invention, the analytes to be testedfor include allergens, including without limitation aesculus, alder,almonds, animal products, artemisia vulgaris, beans, bee sting venom,birch, calyx, cat dander, celeriac, celery, chenopodium album,cockroach, corn, dander, dog dander, drugs, dust mite excretion, eggalbumen, eggs, Fel d 1 protein, fruit, fur, grass, hazel, hornbeam,Insect stings, latex, legumes, local anaesthetics, maize, metal, milk,mold spores, mosquito saliva, mouse dander, nettle, olea, peanuts, peas,pecans, penicillin, Plant pollens, plantago, platanus, poplar, pumpkin,ragweed, rat dander, ryegrass, salicylates, seafood, sesame, sorrel,soy, soybeans, sulfonamides, tilia, timothy-grass, tree nuts, trees,wasp sting venom, weeds, wheat, willow, antibodies against any of theforegoing, or any combination thereof.

According to an embodiment of the invention, the analytes to be testedfor include pollutants, toxins, and contaminants, including withoutlimitation 1,2-Dibromoethane, acrylamide, aldehydes, arsenic, artificialgrowth hormone, asbestos, benzene, benzopyrene, carcinogens,dichloro-diphenyl-trichloroethane, formaldehyde, kepone, lead, mercury,methylmercury, nitrosamines, N-nitroso-N-methylurea, organochlorineinsecticides, pesticides, polychlorinated biphenyls, polychlorinateddibenzofurans, polychlorinated dibenzo-p-dioxins, recombinant bovinegrowth hormone, recombinant bovine somatotropin, toluene, vinylchloride, antibodies against any of the foregoing, or any combinationthereof.

According to an embodiment of the invention, the analytes to be testedfor include analytes with diagnostic or medical value, including withoutlimitation acid phosphatase, active-B12, AFP, Alanine Aminotransferase,Alanine Aminotransferase, Albumin, Albumin BCG, Albumin BCP, AlkalinePhosphatase, Alpha-1 Antitrypsin, Alpha-1 Glycoprotein, Amikacin,Ammonia, Amylase, Anti-CCP, Anti-Tg, Anti-TPO, Apolipoprotein A1,Apolipoprotein B, ASO, Asparate Aminotransferase, AspartateAminotransferase, B12, Beta2 Microglobulin, Beta2 Microglobulin, BNP, CA125, CA 125 II, CA 15-3, CA 19-9 XR, Calcium, Carbamazepine, CarbonDioxide, CEA, Ceruloplasmin, Cholesterol, CK-MB, Complement C3,Complement C4, Cortisol, C-Peptide, C-Reactive Protein, Creatine Kinase,Creatinine, CRP Vario, Cyclosporine, Cyclosporine and Metabolite—WholeBlood, Cyclosporine Monoclonal—Whole Blood, D-Dimer, DHEA-S, Digitoxin,Digoxin, Digoxin II, Digoxin III, Direct Bilirubin, Direct LDL,Estradiol, Ferritin, FLM II, Folate, Free Carbamazepine, Free Phenytoin,Free PSA, Free T3, Free T4, Free Valproic acid, FSH, Gamma-GlutamylTransferase, Gentamicin, Glucose, Glycated Hemoglobin, Haptoglobin, hCG,Hemoglobin, Homocysteine, ICT Cl-, IGFBP-1, Immunoglobulin,Immunoglobulin A, Immunoglobulin E, Immunoglobulin G, Immunoglobulin M,Insulin, Intact PTH, Iron, K+, Kappa Light Chain, Lactate Dehyrogenase,Lactic acid, Lambda Light Chain, LH, Lidocaine, Lipase, Lithium, Lp,Magnesium, metabolites, Methotrexate II, Microalbumin, MPO, Myoglobin,Na+, N-Acetyl-procainamide, Neonatal Bilirubin, NGAL, P-Amylase,Pepsinogen I, Pepsinogen II, Phenobarbital, Phenytoin, Phosphorus,Prealbumin, Procainamide, Progesterone, Prolactin, Quinidine, RheumatoidFactor, SHBG, Sirolimus, STAT CK-MB, T4, Tacrolimus, Tacrolimus II,Testosterone, Tg, Theophylline, Theophylline II,TIBC, TIMP-1,Tobramycin, Total Bilirubin, Total Estriol, Total Protein, Total PSA,Total T3, Total T4, Transferrin, Triglycerides, Troponin-I, Troponin-IADV, TSH, T-Uptake, UIBC, Ultra HDL, Urea Nitrogen, Uric Acid, Urine/CSFProtein, Valproic Acid, Vancomycin, Vancomycin II, Vitamin D, antibodiesagainst any of the foregoing, or any combination thereof.

Receiving Member

According to an embodiment of the invention, the apparatus includes areceiving member, having an opening to receive a fluid sample. Forexample, the receiving member may be dimensioned to receive a fluidcollector. In an embodiment of the invention, the receiving member maybe in fluid communication with other components of the apparatus, forexample at least one membrane test strip, sample retention member,and/or an immunoassay-based fingerprint acquisition pad, throughchannels, for example tubes, piping, channels molded or carved into theapparatus, or any other suitable structure, made of any suitablematerial, for example plastic, ceramic, metal, glass, wood, rubber,polymer, fiber-reinforced polymer, or any combination thereof.

According to an embodiment of the invention, the channel or channelsproviding fluid communication between the components may have differingflow resistance, for example having channels, channel segments, oropenings, that are narrower, wider, longer, or shorter than others,and/or having fluid paths with varying amounts of vertical rise or drop,such that the fluid channels within the device have varying degrees offlow resistance. For example, the channel that provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip may have greater flow resistance than the at leastone channel that provides the fluid communication of the samplereceiving member with the sample retention member, to ensure that aportion of the fluid sample is collected in the sample retention member.

In an embodiment of the invention, a single channel having multipleopenings may connect the receiving member to each of the components ofthe apparatus with which it is in fluid communication, for example theat least one membrane test strip, sample retention member, and/orimmunoassay-based fingerprint acquisition pad.

An embodiment of the invention may accommodate fluids of varyingviscosity, for example water, saliva, urine, and blood. Generally thisis accomplished by varying the diameter of the channel or channels thatprovide the fluid communication of the sample receiving member with theother components of the apparatus, for example providing a wider channeldiameter to accommodate a more viscous fluid.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of water provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of water provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of urine provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of urine provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of saliva provides thefluid communication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of saliva provides thefluid communication of the sample receiving member with the sampleretention member.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of blood provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of blood provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, a channel dimensioned to becompatible with a fluid having the viscosity of mucus provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of mucus provides the fluidcommunication of the sample receiving member with the sample retentionmember.

In an embodiment of the invention, the receiving member may have aninner surface, for example a lower surface, that an absorbent material,such as an absorbent material present in a fluid collector, may becompressed against, thereby expelling the fluid sample from theabsorbent material. For example, the absorbent material may becompressed directly between a compression member present on the fluidcollector and the lower surface of the receiving member, or thereceiving member may provide structural support to facilitatecompression of the absorbent material between a compression member andthe housing that at least partially surrounds the absorbent material.

Sample Retention Member

According to an embodiment of the invention, the apparatus includes asample retention member. The sample retention member may be used tosecurely contain a portion of the fluid sample. The retained portion ofthe fluid sample may be used for further testing, for example forconfirmation of a test result obtained using a membrane test strip, orto test for the presence or absence of other analytes in the fluidsample. The retained portion of the fluid sample may also be used forconfirmation of the test subject's identity through analysis of adistinguishing feature thereof, including without limitation DNA.

According to an embodiment of the invention, the sample retention memberincludes an absorbent material, for example a pad or sponge, or made ofwoven or non-woven fibrous or fabric-like material, for examplecellulose or a cellulose derivative, cotton, hydrophilic foam, woodpulp, polyvinyl alcohol fibers, or any combination thereof. The sampleretention member may include an absorbent material that is part of thesample collection apparatus. The absorbent material may be surrounded bya barrier, such as a liquid-impermeable material, including withoutlimitation plastic, ceramic, metal, glass, wood, rubber, polymer,fiber-reinforced polymer, or any combination thereof, to prevent theretained sample from leaking or evaporating. In an embodiment of theinvention, the absorbent material may be removably attached to theapparatus to facilitate retrieval of the retained fluid sample. In anembodiment of the invention, the absorbent material may be accessedusing a needle, for example by piercing a barrier surrounding theabsorbent material. The retained sample may then be removed, forexample, into a syringe attached to a needle, by means of withdrawal ofthe syringe to create suction.

According to an embodiment of the invention, the sample retention memberincludes a storage container defining a volume for storage of the fluidsample. In an embodiment of the invention, the storage container may beaccessed using a needle to pierce the wall of the storage container. Forexample, the storage container may include a pierceable member, such asa region of decreased wall thickness, and/or made of a soft, pierceable,or breakable material, including without limitation plastic, ceramic,metal, glass, metal foil, wood, rubber, polymer, fiber-reinforcedpolymer, or any combination thereof, that may be pierced. The retainedsample may then be removed, for example, into a syringe attached to aneedle, by means of withdrawal of the syringe to create suction. In anembodiment of the invention, the storage container may be removablyattached to the apparatus, for example through a line of weakness thatmay allow the storage container to be broken free from the apparatus.

According to an embodiment of the invention, the sample retention membercontains substances that facilitate a further use of the sample,including without limitation preservatives or stabilizers able topreserve sample integrity, for example substances able to inhibitmicrobial growth, kill microbes, prevent sample leakage, prevent sampleevaporation, inhibit chemical or enzymatic degradation of substances inthe sample, support survival of cells or other microbes in the sample,or any combination thereof.

According to an embodiment of the invention, the sample retention membermay be bonded to a fingerprint acquisition pad. For example, such a bondmay provide a safeguard against dissociation of the retained sample fromthe fingerprint.

The retained fluid sample may be used for further confirmation testing,including without limitation gas chromatography, liquid chromatography,mass spectrometry, liquid or gas chromatography with tandem massspectrometry, polymerase chain reaction, DNA sequencing, Enzyme-LinkedImmunoSorbent Assay, Western Blotting, culturing for growth, or anycombination thereof, using the retained fluid sample.

Fluid Collector

An embodiment of the apparatus comprises a fluid collector forcollecting a fluid sample. The present invention contemplates collectinga sample from a specific subject, such as a human subject, or testingenvironmental samples, such as testing air, water, soil, or some othersubstance, or a food or beverage, or a liquid extract of any of theforegoing for example, without limitation. The fluid collector isoperative associated with the apparatus. The fluid collector may beremovably associated with the apparatus, affixed to the apparatus, orcomprise multiple units of which one or more is affixed or removablyassociated with the apparatus.

In an embodiment of the invention, the fluid collector includes anabsorbent material capable of absorbing a desired quantity of a fluidsample. The absorbent material may be made of any suitable materialknown to a person in the art, for example, without limitation, a pad orsponge, or woven or non-woven fibrous or fabric-like material, includingwithout limitation cellulose or a cellulose derivative, cotton,hydrophilic foam, wood pulp, polyvinyl alcohol fibers, or anycombination thereof. In an embodiment of the invention, the fluidcollector includes a compression member, able to compress the absorbentmaterial, that may be used to expel air from the absorbent materialprior to collection of the fluid sample and/or to encourage the fluidsample to flow into the absorbent material by creating suction as thecompressed absorbent material returns to the uncompressed state. Acompression member may also be used, for example, to compress theabsorbent material and expel a fluid sample contained therein.

A sufficiency indicator on the collector is contemplated. For examplewithout limitation, a color indicator may either appear or disappearwhen a sufficient sample has been collected, for example when asufficient volume has been absorbed to reach the location in theabsorbent material where the sufficiency indicator is disposed.According to an embodiment of the invention, the sufficiency indicatormay be operatively associated with the absorbent material and mayprotected from direct contact with the source of the fluid sample by abarrier, such as a transparent barrier, for example plastic or glass,such that the fluid sample will only reach the sufficiency indicator bypassing into the absorbent material.

The sufficiency indicator color may be in the shape of a word or symbolthat appears or disappears when a sufficient sample has been collected.For example, the sufficiency indicator may a diffusible dye, whereindilution of the dye by the fluid sample causes a color to disappear,indicating that a sample of sufficient volume has been collected. In anembodiment of the invention, a combination of a non-diffusible anddiffusible dye may be used together, such that the non-diffusible dyeremains and provides an informative message when the diffusible dyedisappears, for example the diffusible dye may form the letters “in” inthe word “insufficient” such that the non-diffusible dye remains andforms the word “sufficient” when a sufficient sample has been collected.

The sufficiency indicator may be a pH-sensitive substance that changescolor when the sample is encountered. For example, multiple pH sensitiveindicators responding to different pH values may be present, such that acolor change is observed whether the sample is acidic, basic, orneutral. According to an embodiment of the invention, a pH-changingsubstance, such as an acid or base, may be disposed within the absorbentmaterial, such that the sample will be of the correct pH to elicit thedesired color change in the sufficiency indicator.

A closure member may be used. The closure member is capable of sealingthe open end of a sample receiving member when the fluid collector isinserted into the open end of a sample receiving member. For example,the closure member may be dimensioned to fit closely in the opening inthe open end of the receiving member, and the closure member or the openend of the receiving member may include a compressible material,including without limitation natural rubber such as vulcanized rubber,synthetic rubber such as neoprene or nitrile rubber, plastic, ceramic,or any combination thereof, disposed at the interface between theclosure member and the opening in the open end of the sample receivingmember, capable of creating a seal, such as an airtight or a watertightseal, when the sample receiving member receives the fluid collector.

After the fluid collector has been inserted into the sample receivingmember, a device for securing the fluid collector within the samplereceiving member is contemplated. The means for securing may preventremoval of the fluid collector from the sample receiving member after ithas been inserted therein. The means for securing the fluid collectorwithin the sample receiving member may include at least one projectionextending from the fluid collector that cooperates with the at least oneprojection located on the inner surface of the sample receiving member,where such projections may include for example at least one locking taband/or at least one annular ring. According to an embodiment of theinvention, a closure member on the fluid collector may form asufficiently secure closure as to constitute means for securing thefluid collector within the sample receiving member.

The sample receiving member may also include a tamper-evident seal, suchthat attempting to tamper with the contents of the apparatus will resultin a visual indicator, for example by tears or breakage visible in animprinted seal, for example tape or adhesive-backed foil havingcharacters, symbols or a signature on a surface. Such a tamper-evidentseal may be placed on the apparatus before its use, to create a visualconfirmation that the contents of the apparatus have not been alteredvia the open end of the receiving member prior to testing, or after itsuse, to create a visual confirmation that the contents of the apparatushave not been altered via the open end of the receiving membersubsequent to testing. According to an embodiment of the invention, themeans for securing the fluid collector within the sample receivingmember may constitute a tamper evident seal, in that attempted removalof the fluid collector from the sample receiving member after it hasbeen inserted therein may result in visible damage to the apparatus.

According to an embodiment of the invention, the fluid collectorincludes a handle, for example made of wood, plastic, ceramic, or metal,and disposed, for example, at the end distal to the absorbent material.The handle may be removably attached, for example through aninterference fit, adhesive, glue, or epoxy, that breaks or separateswhen the handle is twisted and/or pulled, or by a structure that allowsthe handle to be broken away, for example, a line of weakness.

The fluid collector may include a housing that at least partiallysurrounds the absorbent material. The housing may have multiple openingsto allow the fluid sample to be absorbed by and expressed from theabsorbent material. The openings in the housing may contain filtrationmembers able to strain particulates from the fluid sample, resulting inreduction of the number of particulates that enter the absorbentmaterial. The fluid collector may include a compression member able tocompress the absorbent material against the housing. For example, thehousing may be slidably coupled to a compression member with theabsorbent material disposed between the compression member and an innersurface of the housing, such that the absorbent material may becompressed by movement of the compression member towards an innersurface of the housing. An embodiment of the invention includes meansfor securing the absorbent material in the compressed state, includingwithout limitation cooperating threads, projections, and/or groovesoperatively associated with the compression member and the housing. Theabsorbent material may be released from the compressed state before,concurrently with, or after encounter with the fluid sample,facilitating entry of the fluid sample into the absorbent material asthe absorbent material returns to the relaxed state, creating suction.For example, the absorbent material may be operatively associated with aspring, such that compression of the absorbent material results incompression of the spring, and when compression is released the springassists return of the absorbent material to the uncompressed state.

In an embodiment of the invention, the fluid collector is operativelyassociated with the lid of a fluid container including withoutlimitation a urine cup. For example, the absorbent material may bedisposed on the inner side of the lid, such that attachment of the lidto the fluid container results in contact between the absorbent materialand a fluid sample. In certain embodiments of the invention, a portionof the fluid collector including the lid may be removably associatedwith a portion of the fluid collector including the absorbent material,allowing the absorbent material to be separated from the lid. Theoperative association of the fluid collector with the lid may includemeans for arresting the rotation of part of the fluid collector relativeto the lid, including without limitation cooperating projections presenton one member and grooves or slots present on the other member, forexample to facilitate release of means by which the absorbent materialis fixed in the compressed state.

Saliva Producing Substances

Use of a saliva producing substance is contemplated by the presentinvention. Saliva producing substances elicit or increase salivaproduction in the test subject. For example, without limitation, thesaliva producing substance may sugars, salts, acids, or any combinationthereof. In an embodiment of the invention, the saliva producingsubstance may be associated with a fluid collector, for example locatedon or in the absorbent material or the housing. In an embodiment of theinvention, the saliva producing substance may be separated from thefluid collector, for example in the form of a gum, candy, or powder, foradministration to the test subject before, during or after the fluidcollector is inserted into the test subject's mouth.

For example, without limitation, the sugar may be a monosaccharide, adisaccharide, a trisaccharide, an oligosaccharide, a polysaccharide,acarbose, allose, altrose, amylose, arabinose, cellobiose, cyclodextrin,alpha-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin, deoxyglucose,dextrin, dihydroxyacetone, erythrose, erythrulose, ficoll,fructo-oligosaccharides, fructose, galacto-oligosaccharides, galactose,gentiobiose, glucosamine, glucose, glyceraldehyde, glycogen, gulose,idose, inositol, inulin, isomaltose, lactose, lyxose, maltose,maltosyl-cyclodextrin, malt-triose, mannan-oligosaccharides,mannoheptulose, mannose, melezitose, monnitol, psicose, raffinose,ribitol, ribose, ribulose, sedoheptulose, sorbitol, sorbose, sucrose,tagatose, talose, threose, trehalose, xylose, xylulose, or anycombination thereof.

For example, without limitation, the salt may an inorganic salt, organicsalt, acid salt, alkali salt, neutral salt, or amino acid salt, or anycombination thereof. The salt may include a cation and an anion, forexample without limitation thereto, the cation may be aluminium,ammonium, barium, beryllium, calcium, cesium, chromium(II),chromium((III), chromium(VI), cobalt(II), cobalt((III), copper(I),copper(II), copper(III), gallium, helium, hydrogen, hydronium, iron(II),iron((III), lead(II), lead(IV), lithium, magnesium, manganese(II),manganese(III), manganese(IV), manganese(VII), nickel(II), nickel(III),nitronium, potassium, pyridinium, silver, sodium, strontium, tin(II),tin(IV), zinc, or any combination thereof, and an anion may be acetate,amide, tartrate, borate, bromate, bromide, carbonate, chlorate,chloride, chlorite, chromate, citrate, cyanate, dichromate, dihydrogenphosphate, fluoride, formate, glutamate, hydride, hydrogen carbonate,hydrogen oxalate, hydrogen phosphate, hydrogen sulfate, hydrogensulfite, hydroxide, hypobromite, hypochlorite, iodate, iodide, nitrate,nitride, nitrite, oxalate, oxide, perchlorate, permanganate, peroxide,phosphate, phosphide, phosphite, pyrophosphate, sulfate, sulfide,sulfite, telluride, thiocyanate, thiosulfate, or any combinationthereof. For example, according to an embodiment of the invention, thesalt may be sodium chloride or potassium chloride.

The acid may be any suitable acid known to a person skilled in the art,for example acetic acid, acrylic acid, adipic acid, alginic acid,alkanesulfonic acid, amino acid, ascorbic acid, benzoic acid, boricacid, butyric acid, carbonic acid, carboxylic acid, citric acid, fattysacid, folic acid, formic acid, fumaric acid, gluconic acid, hydriodicacid, hydrobromic acid, hydrochloric acid, hydroquinosulfonic acid,isoascorbic acid, lactic acid, maleic acid, malic acid, malonic acid,methanesulfonic acid, nitric acid, oxalic acid, p-toluenesulfonic acid,para-bromophenylsulfonic acid, phosphoric acid, propionic acid,salicylic acid, stearic acid, succinic acid, sulfuric acid, tannic acid,tartaric acid, thioglycolic acid, toluenesulfonic acid, uric acid, orany combination thereof.

Fingerprint Identification

An embodiments of the present invention includes a fingerprint pad toprovide identification of an individual associated with the test, suchas the test subject, test administrator, and/or one or more witnesses.The fingerprint pad may employ any suitable fingerprinting methodology,for example, without limitation, ink-based, immunoassay-based,electronic, semi-inkless, or inkless. In an embodiment of the invention,the fingerprint pad may be able to collect multiple fingerprints, forexample having multiple fingerprint pads, having one fingerprint pad ofsufficient size to accommodate multiple fingerprints, or having anelectronic fingerprint pad.

The fingerprint pad may be an ink-based fingerprint pad. An embodimentof the invention includes a dispenser able to dispense an ink that canelicit a signal in the ink-based fingerprint pad. The fingerprint padmay also be inkless or semi-inkless, for example requiring no ink orcompatible with an activator that appears transparent on the subject'sskin, is readily cleaned off of the subject's skin, or readilydisappears, for example when the subject's hands are rubbed together.According to an embodiment of the invention, the inkless fingerprint padmay be immunoassay-based, for example as described within U.S. Pat. No.6,352,863 to Raouf A. Guirguis, issued Mar. 5, 2002 (the “'863 patent”),and U.S. Pat. No. 5,244,815 to Raouf A. Guirguis, issued Sep. 14, 1993(the “'815 patent”), which are incorporated herein by reference in theirentirety. The immunoassay-based fingerprint pad may or may not be influid communication with a sample receiving member. Other embodiments ofthe invention may incorporate various features of the embodimentsdisclosed within the '863 and '815 patents. In embodiment of theinvention having an inkless or semi-inkless fingerprint pad thatrequires an activator to elicit a signal, the apparatus may also includea dispenser to dispense the activator. According to an embodiment of theinvention, the fingerprint pad may have a surface, such as an absorbentor adhesive surface, able to gather sweat, oils, and/or skin cells whena finger is pressed against it, that may require further processing topermit clear visualization of the fingerprint.

According to an embodiment of the invention, an inkless fingerprint padmay be an electronic fingerprint pad, including without limitation anoptical scan fingerprint reader or a solid-state fingerprint reader. Anembodiment of the invention includes a memory element, including withoutlimitation volatile or non-volatile memory, for example a hard disk,floppy disk, magnetic tape, optical disk, flash memory, holographicmemory, EEPROM, RAM, DRAM, SDRAM, or SRAM coupled to the fingerprint padfor storage of one or more fingerprints. According to an embodiment ofthe invention, the electronic fingerprint pads may have electricallycharged surface elements, wherein portions of the surface areelectrically discharged upon contact with the finger surface, such asthe ridges of the finger surface, such that the fingerprint is recordedin the pattern of discharged elements, whereby the fingerprint patternmay be stably stored within the surface for a time after it is createduntil it is read, for example through connection of the apparatus withan external device, including without limitation a base station. Anembodiment of the invention include means of transmission of thecaptured fingerprint, for example to an external device or network,including without limitation through a hard-wired connection, forexample employing wires, cables, or a docking station or dockingconnector, for employing a connection including without limitation USB,IEEE 1394, serial, parallel, or SCSI, or a wireless connection, forexample employing infrared, RF, IEEE 802.11, Bluetooth, IEEE 802.15, orWi-Fi.

In an embodiment of the invention, a cover encloses the fingerprintacquisition pad. The cover may be secured using various mechanisms, forexample, without limitation, a tab-and-slot connector, latch, springlatch, adhesive tape, or security tape. The cover may be secured priorto fingerprint acquisition and/or after fingerprint acquisition.

FIGS. 1-5 depict a fluid collection and analyte testing device inaccordance with an embodiment of the present invention. Analytescreening device 10 includes a fluid collector 20, to collect a fluidsample from a test subject, and a housing 30 to test and retain thefluid sample. The housing 30 contains a collection chamber 40, toreceive the fluid collector 20 through an opening 32, at least onemembrane test strip 51, to indicate the presence or absence of at leastone analyte, and an immunoassay-based fingerprint acquisition pad 60 topositively identify an individual associated with the test. Thecollection chamber 40 is in fluid communication, with the membrane teststrips 51 and the immunoassay-based fingerprint acquisition pad 60.

Referring still to FIGS. 1-5, the fluid collector 20 receives a fluidsample from a test subject and temporarily stores the fluid sample untilit is transferred to the housing 30. Generally, any material capable ofacquiring and storing a fluid sample may be used. A sponge 25 isattached to one end of the fluid collector 20 to absorb, and temporarilystore, the fluid sample. The sponge 25 may be saturated with asaliva-producing substance. After the fluid sample has been collected,the fluid collector 20 is inserted into the collection chamber 40through the opening 32, and the fluid sample is expelled by compressingthe sponge 25 against the bottom surface of the lower portion 42 of thecollection chamber 40, thereby releasing the entrapped fluid into theapparatus.

Referring still to FIGS. 1-5, the fluid collector 20 includes a centralshaft 22, a disk 21, disposed at the upper end of the central shaft 22,a disk 24, disposed at the lower end of central shaft 22, and a handle23 attached to the upper surface of the disk 21. The diameter of disk 21is slightly larger than the diameter of disk 24. Additionally, sealingrings 28 and 29 may be attached to the outer circumference of disks 21and 24, respectively. Generally, the dimensions of disks 21 and 24, andsealing rings 28 and 29, comport with the interior dimension ofcollection chamber 40 in order to prevent fluid from escaping throughthe opening 32. Sponge 25 is attached to the lower surface of disk 24and is dimensioned to be slightly smaller in diameter than disk 24 toallow for radial expansion within the lower portion 42 of the collectionchamber 40 when the sponge 25 is under compression.

Referring still to FIGS. 1-5, as is discussed in more detail below, thefluid collector 20 becomes secured within the collection chamber 40after the fluid collector 20 is inserted into the collection chamber 40to a predetermined depth. If desired, handle 23 a may then be brokenaway from the upper surface of disk 21. The analyte screening device 10also includes a window 36 through which the secured fluid collector 20may be viewed. The cover 37 encloses immunoassay-based fingerprintacquisition pad 60, and is attached to the housing 30 by the hinges 38.The cover 37 may be secured after the fingerprint of the test subjecthas been acquired, using various locking mechanisms, including withoutlimitation a tab-and-slot arrangement, or security tape Furtherconfirmation testing may be performed, using the secured fluid sample.Access to the fluid sample may be obtained, for example, by simplyremoving the immunoassay-based fingerprint acquisition pad 60 to exposeadapter 61 and tube 46, by puncturing the immunoassay-based fingerprintacquisition pad 60 with a needle to access adapter 61 and tube 46.

Referring still to FIGS. 1-5, the test cartridge 50, containing themembrane test strips 51, may be inserted into a test cartridge chamber34 through an opening 33. Advantageously, different versions of the testcartridge 50 may be developed to test different combinations ofanalytes, thereby allowing the test administrator to select theappropriate analyte test suite at the test site. The test cartridgechamber 34 includes a locking mechanism 35 to secure the test cartridge50 within the test cartridge chamber 34, thereby preventing the removalof the test cartridge 50 from housing 30. The locking mechanism 35cooperates with corresponding structure located on the test cartridge50. An opening or window 31 in the housing 30 allows a portion of thetest cartridge 50 to be viewed, including, of course, the test andcontrol regions of the membrane test strips 51.

Referring still to FIGS. 1-5, each membrane test strip 51 generallyindicates the presence or absence of at least one analyte. A singledrug, or class of drugs, is indicated by each membrane test strip 51,including without limitation, for example, cocaine (COC), amphetamine(AMP), methamphetamine (mAMP), marijuana (THC), methadone (MTD),phencyclidine (PCP), morphine, barbiturates, benzodiazepines, oralcohol.

Referring still to FIGS. 1-5, immunoassay-based fingerprint acquisitionpad 60 includes a compressible, porous reaction medium, having a controlzone and a plurality of reaction zones, arranged on a porous support.The control zone includes a control reagent to identify the fluid sampledonor, and each reaction zone includes a reaction reagent to determinethe presence of a specific analyte in the fluid sample. The controlreagent includes a member of a predetermined ligand/receptor bindingpair. Similarly, each reaction reagent includes a member of apredetermined ligand/receptor binding pair. Various ligand/receptorbinding pairs for use within the control and reaction zones arediscussed within the '863 and '815 patents.

Referring still to FIGS. 1-5, immunoassay-based fingerprint acquisitionpad 60 is fluidicly coupled to the collection chamber 40. Asignal-producing agent, located on upper surface of the porous supportor the lower surface of the reaction medium, mixes with the fluid sampleprovided to the immunoassay-based fingerprint acquisition pad 60. Theproduction of an image or pattern which identifies the person providingthe sample is accomplished by applying a fingertip to the upper surfaceof the reaction medium and compressing the reaction medium so that thefluid sample/signal-producing agent mixture permeates the reactionmedium, and allowing the control zone ligand/receptor reaction to takeplace so that the members of this immunological pair bond with thesignal-producing agent and produce the fingerprint image. Similarly, thepresence or absence of a specific analyte in the fluid sample isindicated within each reaction zone by the reaction of each specificreaction reagent with the fluid sample/signal-producing agent mixture.

Referring still to FIGS. 1-5, a piping system fluidicly couples thecollection chamber 40 to the membrane test strips 51 and theimmunoassay-based fingerprint acquisition pad 60. Tube 43 fluidiclycouples the lower portion 42 of the collection chamber 40 to adapter 44and test cartridge fluid reservoir 45. Similarly, tube 46 fluidiclycouples the lower portion 42 of collection chamber 40 to adapter 61,located just beneath immunoassay-based fingerprint acquisition pad 60.Although tubes 43 and 46 are shown to be individually connected to thelower portion 42 of collection chamber 40, other configurations are alsopossible. For example, tube 43 may be the only connection to the lowerportion 42 of collection chamber 40. In this example, a “T” connectionmay be incorporated into tube 43 to fluidicly couple tube 46 toimmunoassay-based fingerprint acquisition pad 60. Alternatively, therequired fluid connections may be molded directly within the housing 30.

FIGS. 6-8 depict a fluid collection and analyte testing device inaccordance with an embodiment of the present invention. Analytescreening device 100 includes membrane test strips 151 attached directlyto housing 30. The membrane test strips are coupled to a fluid reservoir145. Several analytes are indicated by each membrane test strip 151,including without limitation, for example, cocaine (COC),methamphetamine (mAMP) and phencyclidine (PCP) (leftmost strip),marijuana (THC), opiates and amphetamine (AMP) (middle strip) andmethadone (MTD) (rightmost strip). In additional to recognizedstandards, minimum concentration levels at which a positive reaction isproduced, that is, no visible line in the test region of the membranetest strip, may include, for example, amphetamine (50 ng/mL),methamphetamine (50 g/mL), a cocaine metabolite includingbenzoylecgnonine and ecgonine methyl ester (20 ng/mL), an opiateincluding morphine, codeine and heroine (40 ng/mL), marijuana (THC COOH)(12 ng/mL) and phencyclidine (10 ng/mL). Several openings or windows 131in the housing 30 allow the test and control regions of the membranetest strips 151 to be viewed.

Referring still to FIGS. 6-8, the fluid collector 20 receives a fluidsample from a test subject and temporarily stores the fluid sample untilit is transferred to the housing 30. The fluid collector 20 is theninserted into the collection chamber 40 through the opening 32, and thefluid sample is extracted therefrom by compressing the sponge 25 againstthe bottom surface of the lower portion 42 of the collection chamber 40,thereby releasing the entrapped fluid into the tubes 43 and 46.Projections 26 extend from the upper surface of disk 21 and cooperatewith an annular projection 46, located on the inner surface of thecollection chamber 40, to secure the fluid collector 20 within thecollection chamber 40.

Referring to FIGS. 7-8, after the fluid collector 20 is inserted apredetermined distance, the projections 26 engage the annular projection46 to prevent the fluid collector 20 from being extracted from thecollection chamber 40. Although four projections are depicted, at leasttwo should be used to effectively secure the fluid collector 20 withinthe collection chamber 40. Alternatively, the annular projection 46 maycooperate with a projecting circumferential ring (not show), locatedabove the sealing ring 28 of disk 21, to secure the fluid collector 20within the collection chamber 40. As an additional measure of security,handle 23 a may be detached from the fluid collector 20 along a line ofweakness 27 after the fluid collector 20 has engaged the annularprojection 46. If a twisting motion is desired to detach the handle 23from the fluid collector 20, then one (or more) stop(s) 47 may belocated just below the annular projection 46 to prevent the fluidcollector 20 from rotating by engaging one (or more) of the projections26.

Referring to FIG. 9 , analyte screening device 200 includes a window 37incorporating a sealable opening 49 that allows access to the collectionchamber 40. When the fluid collector 20 is secured within the collectionchamber 40, sealable opening 49 allows access to a confirmation chamber47 formed between the disks 21 and 24. A passage 48 fluidicly couplesthe lower portion 42 of the collection chamber 40 to the confirmationchamber 47 to allow a portion of the fluid sample to flow into theconfirmation chamber 47 as the fluid collector 20 is inserted into thecollection chamber 40. Once the fluid collector 20 is secured with thecollection chamber 40, a portion of the fluid sample is available forconfirmation sampling through the sealable opening 49.

Referring still to FIG. 9, immunoassay-based fingerprint acquisition pad60 is not fluidicly coupled to the collection chamber 40. Instead, aportion of the fluid sample is extracted through the sealable opening49, using, for example, a pipette, and applied to the upper surface ofimmunoassay-based fingerprint acquisition pad 60. A signal-producingagent is applied to the person's fingertip, or, alternatively, thesignal-producing agent may be located on the upper surface of the poroussupport or the lower surface of the reaction medium. Thesignal-producing agent then mixes with the fluid sample provided to theimmunoassay-based fingerprint acquisition pad 60. The production of animage or pattern which identifies the person providing the sample isaccomplished by applying a fingertip to the upper surface of thereaction medium and compressing the reaction medium so that the fluidsample permeates the reaction medium, and allowing the predeterminedligand/receptor reaction to take place so that the members of theimmunological pair bond with the signal-producing agent and produce thefingerprint image. Similarly, the presence or absence of a specificanalyte in the fluid sample is indicated within each reaction zone bythe reaction of each specific reaction reagent with the fluidsample/signal-producing agent mixture.

Referring to FIG. 10, a fluid collector 500 rests in a fluid collectorholder 450 attached to analyte testing device 400. The fluid collector500 includes an upper segment 510 having an upper surface 513, a closuremember 517, and a sealing member 518; a shaft 540; a housing 560 havingseveral lateral openings 561, lower openings 564, and lower surface 562and containing absorbent material 550. The analyte testing device 400includes a receiving member 410 having an open end 415; a membrane teststrip 420; a window 430 for viewing of the membrane test strip; a lowerfluid channel 440; and an upper fluid channel 445.

Referring to FIG. 11, after a fluid sample has been absorbed byabsorbent material 550 the fluid collector 500 is inserted into the openend 415 of the receiving member 410.

Referring to FIG. 12, compression of the upper surface 513 of the fluidcollector 500 has caused closure element 517 to seat in the open end 415of the receiving member 410, where sealing member 518 forms a seal. Thefluid collector 500 has been fully inserted into the testing device 400,and the absorbent material 550 has been compressed between thecompression element 545 and the lower surface 562 of the housing 560,causing the fluid sample to be expelled through openings 561. The fluidsample flows through lower channel 440 and encounters the proximal end421 of the membrane test strip 420 and begins to upward towards theupper end 427 of the membrane test strip 420 by capillary action. Once asufficient volume of the fluid sample has entered the lower channel 440,the fluid level rises until excess fluid flows through upper channel 445and enters an absorbent pad, sample retention member 460.

Referring to FIG. 13, the fluid sample fills the lower channel 440before flowing into the upper channel 445 to enter the sample retentionmember 460. The sample retention member 460 is bonded to fingerprintacquisition pad 480, which is covered by the rear door 470.

Referring to FIG. 14, the fingerprint acquisition pad is covered by therear door 470 which is held closed by closure member 477 and pivots intothe opened position on the axis defined by the hinges 475.

Referring to FIG. 15, the rear door, fingerprint acquisition pad, andsample retention member are hidden to show a rear view of the upperchannel 445 through which the fluid sample flows to enter the sampleretention member. The closure member of the rear door cooperates withlatch member 478 to secure the door in the closed position.

Referring to FIG. 16, the left and right panels show exterior andcross-sectional views, respectively, of a fluid collector 500. The fluidcollector 500 includes a spring 555 that is co-axial with the directionof compression of absorbent material 550, such that compression of theabsorbent material 550 results in compression of the spring 555, andrelease of the compressive force causes the spring 555 to assist thereturn of the absorbent material 550 to the relaxed state, creatingsuction that draws the fluid sample into the absorbent material 550.

Referring to FIG. 17, a urine cup 600 able to receive a fluid collectorhas a lid 610 having an opening 615 leading to the interior ofsupporting member 620 having openings 625 through which the fluid samplecan flow, and slot 627 that cooperates with the fluid collector.

Referring to FIG. 18, a fluid sample collector 700 has been insertedthrough the opening 615 into the interior of the supporting member 620,and a tab 762 disposed on the lower end of the fluid sample collectorhas engaged slot 627, whereby housing 760 is prevented from rotatingrelative to the urine collection cup 600. The absorbent material 750 iscompressed between the compression member 745 and the lower surface 762of the housing. When the compressive force is released, a spring 755co-axial with absorbent material 750 assists the return of absorbentmaterial 750 to the relaxed state, creating suction that helps draw thefluid sample into the absorbent material 750. The sample collection 700apparatus also includes upper segment 710 having an upper surface 713through which compressive force is delivered to the absorbent material750, a closure member 717, a sealing member 718, and a shaft 740.

Although this invention has been described in conjunction with specificembodiments thereof, many alternatives, modifications and variationswill be apparent to those skilled in the art. Accordingly, the preferredembodiments of the invention as set forth herein, are intended to beillustrative, not limiting. Various changes may be made withoutdeparting from the true spirit and full scope of the invention as setforth herein.

1. An apparatus comprising: a sample receiving member, having an openingfor receiving a fluid sample; a sample retention member, in fluidcommunication with the sample receiving member, to retain a portion ofthe fluid sample; and at least one membrane test strip, in fluidcommunication with the sample receiving member, to indicate the presenceor absence of at least one analyte in the fluid sample.
 2. The apparatusof claim 1, further comprising a fluid collector to collect the fluidsample and convey the fluid sample into the sample receiving member. 3.The apparatus of claim 2, wherein the fluid collector comprises: anabsorbent material to absorb the fluid sample; a compression memberoperatively associated with the absorbent material; and a closure membercapable of sealing the open end of the sample receiving member when thefluid collector is inserted in the sample receiving member.
 4. Theapparatus of claim 3, wherein the closure member is capable of creatingan airtight seal in the open end of the sample receiving member.
 5. Theapparatus of claim 3, further comprising means for securing the fluidcollector within the sample receiving member after the fluid collectorhas been inserted into the sample receiving member.
 6. The apparatus ofclaim 5, wherein the means for securing the fluid collector within thesample receiving member comprise at least one annular projection withinthe sample receiving member.
 7. The apparatus of claim 3, wherein thefluid collector further comprises a handle removably attached to theupper surface of the first disk.
 8. The apparatus of claim 3, furthercomprising a saliva-producing substance.
 9. The apparatus of claim 8,wherein the saliva-producing substance comprises sugar, salt, acid, orany combination thereof.
 10. The apparatus of claim 9, wherein thesaliva-producing substance comprises sodium chloride, citric acid, orany combination thereof.
 11. The apparatus of claim 1, furthercomprising a fingerprint acquisition pad.
 12. The apparatus of claim 11,wherein the fingerprint acquisition pad is enclosed by a cover attachedto the housing.
 13. The apparatus of claim 11, wherein the fingerprintacquisition pad is an ink-based fingerprint acquisition pad.
 14. Theapparatus of claim 13, further comprising a dispenser able to dispensean ink that can elicit a signal in the ink-based fingerprint acquisitionpad.
 15. The apparatus of claim 11, wherein the fingerprint acquisitionpad is an inkless fingerprint acquisition pad.
 16. The apparatus ofclaim 15, further comprising a dispenser able to dispense an activatorthat can elicit a signal in the inkless fingerprint acquisition pad. 17.The apparatus of claim 15, wherein the inkless fingerprint acquisitionpad is an immunoassay-based fingerprint acquisition pad.
 18. Theapparatus of claim 17, wherein the immunoassay-based fingerprintacquisition pad is in fluid communication with the sample receivingmember.
 19. The apparatus of claim 18, wherein a channel provides thefluid communication between the sample receiving member and the at leastone membrane test strip and the fluid communication between the samplereceiving member and the immunoassay-based fingerprint acquisition pad.20. The apparatus of claim 19, further comprising a dispenser able todispense a signal-producing agent that can elicit a signal in theimmunoassay-based fingerprint acquisition pad.
 21. The apparatus ofclaim 11, wherein the fingerprint acquisition pad is an electronicfingerprint acquisition pad.
 22. The apparatus of claim 21, furthercomprising means for storage of a fingerprint image captured by thefingerprint acquisition pad.
 23. The apparatus of claim 21, furthercomprising means for transmission of the fingerprint image.
 24. Theapparatus of claim 23, wherein the transmission is a wirelesstransmission.
 25. The apparatus of claim 11, wherein the sampleretention member comprises an absorbent material.
 26. The apparatus ofclaim 25, wherein a single channel having multiple openings provides thefluid communication of the sample receiving member with the at least onemembrane test strip and the fluid communication of the sample receivingmember with the sample retention member.
 27. The apparatus of claim 25,wherein the absorbent material is bonded to the fingerprint acquisitionpad.
 28. The apparatus of claim 11, wherein the sample retention memberis a storage container defining a volume for storage of the fluidsample.
 29. The apparatus of claim 28, wherein the storage container isbonded to the fingerprint acquisition pad.
 30. The apparatus of claim29, wherein the storage container is removably attached to theapparatus.
 31. The apparatus of claim 28, wherein the storage containermay be punctured with a needle to access the fluid contained therein.32. The apparatus of claim 1, wherein at least one channel provides thefluid communication of the sample receiving member with the at least onemembrane test strip and at least one channel provide the fluidcommunication of the sample receiving member with the sample retentionmember, wherein the at least one channel that provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip has greater flow resistance than the at least onechannel that provides the fluid communication of the sample receivingmember with the sample retention member, to ensure that a portion of thefluid sample is collected in the sample retention member.
 33. Theapparatus of claim 1, wherein at least one channel dimensioned to becompatible with a fluid having the viscosity of water provides the fluidcommunication of the sample receiving member with the at least onemembrane test strip and at least one channel dimensioned to becompatible with a fluid having the viscosity of water provides the fluidcommunication of the sample receiving member with the sample retentionmember.
 34. The apparatus of claim 1, wherein at least one channeldimensioned to be compatible with a fluid having the viscosity of urineprovides the fluid communication of the sample receiving member with theat least one membrane test strip and at least one channel dimensioned tobe compatible with a fluid having the viscosity of urine provides thefluid communication of the sample receiving member with the sampleretention member.
 35. The apparatus of claim 1, wherein at least onechannel dimensioned to be compatible with a fluid having the viscosityof saliva provides the fluid communication of the sample receivingmember with the at least one membrane test strip and at least onechannel dimensioned to be compatible with a fluid having the viscosityof saliva provides the fluid communication of the sample receivingmember with the sample retention member.
 36. The apparatus of claim 1,wherein at least one channel dimensioned to be compatible with a fluidhaving the viscosity of blood provides the fluid communication of thesample receiving member with the at least one membrane test strip and atleast one channel dimensioned to be compatible with a fluid having theviscosity of blood provides the fluid communication of the samplereceiving member with the sample retention member.
 37. The apparatus ofclaim 1, wherein each of the at least one membrane test strip includes:a dye region, disposed at a proximal end of the membrane test strip,including labeled antibodies reactive against one or more of the atleast one analyte and at least one labeled control protein; a controlregion, disposed at the distal end of the membrane strip, includingantibodies reactive against the at least one labeled control protein;and at least one test region, wherein each of the at least one testregion is disposed on the membrane test strip between the dye region andthe control region and includes at least one competitor able to bind theantibodies reactive against one or more of the at least one analyte. 38.The apparatus of claim 37, wherein the test region displays a visualindicator when the concentration of an analyte in the fluid sample isbelow a predetermined threshold.
 39. The apparatus of claim 37, whereinthe control region displays a visual indicator when the first volume offluid received from the fluid collector is above a predeterminedthreshold and proper membrane wicking has occurred.
 40. The apparatus ofclaim 39, wherein the predetermined threshold is 200 microliters. 41.The apparatus of claim 1, wherein each of the at least one membrane teststrip includes: a dye region, disposed at a proximal end of the membranetest strip, including labeled antibodies reactive against one or more ofthe at least one analyte and at least one labeled control protein; acontrol region, disposed at the distal end of the membrane strip,including antibodies reactive against the at least one labeled controlprotein; and at least one test region, wherein each of the at least onetest region is disposed on the membrane test strip between the dyeregion and the control region and includes antibodies reactive againstone or more of the at least one analyte.
 42. The apparatus of claim 41,wherein the test region displays a visual indicator when theconcentration of an analyte in the fluid sample is above a predeterminedthreshold.
 43. The apparatus of claim 41, wherein the control regiondisplays a visual indicator when the first volume of fluid received fromthe fluid collector is above a predetermined threshold and propermembrane wicking has occurred.
 44. The apparatus of claim 43, whereinthe predetermined threshold is 200 microliters.
 45. The apparatus ofclaim 1, wherein the at least one analyte in the fluid sample isamphetamine, methamphetamine, a cocaine metabolite, an opiate, THC-COOH,phencyclidine, or any combination thereof.
 46. The apparatus of claim45, wherein absence of a visible signal in a test region of the at leastone membrane test strip indicates that an analyte is not present above apredetermined threshold concentration in the fluid sample.
 47. Theapparatus of claim 45, wherein presence of a visible signal in a testregion of the at least one membrane test strip indicates that an analyteis present above a predetermined threshold concentration in the fluidsample.
 48. An apparatus comprising: a sample receiving member, havingan opening for receiving a fluid sample; a fluid collector to collectthe fluid sample and convey the fluid sample into the sample receivingmember; at least one membrane test strip, in fluid communication withthe sample receiving member, to indicate the presence or absence of atleast one analyte in the fluid sample, and a fingerprint acquisitionpad.
 49. The apparatus of claim 48, further comprising a sampleretention member, in fluid communication with the sample receivingmember, to retain a portion of the fluid sample.
 50. The apparatus ofclaim 49, wherein the sample retention member comprises an absorbentmaterial.
 51. The apparatus of claim 50, wherein the absorbent materialis bonded to the fingerprint acquisition pad.
 52. The apparatus of claim48, further comprising a saliva-producing substance.
 53. The apparatusof claim 48, wherein the fluid collector comprises: an absorbentmaterial, to absorb the fluid sample; a compression member operativelyassociated with the absorbent material; and a closure member, capable ofsealing the open end of the sample receiving member when the fluidcollector is inserted in the sample receiving member.
 54. The apparatusof claim 48, wherein the fingerprint acquisition pad is enclosed by acover attached to the housing.
 55. The apparatus of claim 48, whereinthe fingerprint acquisition pad is selected from the group consisting ofan ink-based fingerprint acquisition pad, an inkless fingerprintacquisition pad, an immunoassay-based fingerprint acquisition pad, andan electronic fingerprint acquisition pad.
 56. The apparatus of claim48, further comprising a dispenser able to dispense an activator thatcan elicit a signal in the fingerprint acquisition pad.
 57. Theapparatus of claim 48, wherein each of the at least one membrane teststrip includes: a dye region, disposed at a proximal end of the membranetest strip, including labeled antibodies reactive against one or more ofthe at least one analyte and at least one labeled control protein; acontrol region, disposed at the distal end of the membrane strip,including antibodies reactive against the at least one labeled controlprotein; and at least one test region, wherein each of the at least onetest region is disposed on the membrane test strip between the dyeregion and the control region and includes at least one competitor ableto bind the antibodies reactive against one or more of the at least oneanalyte.
 58. The apparatus of claim 48, wherein absence of a visiblesignal in a test region of the at least one membrane test stripindicates that an analyte is not present above a predetermined thresholdconcentration in the fluid sample.
 59. The apparatus of claim 48,wherein each of the at least one membrane test strip includes: a dyeregion, disposed at a proximal end of the membrane test strip, includinglabeled antibodies reactive against one or more of the at least oneanalyte and at least one labeled control protein; a control region,disposed at the distal end of the membrane strip, including antibodiesreactive against the at least one labeled control protein; and at leastone test region, wherein each of the at least one test region isdisposed on the membrane test strip between the dye region and thecontrol region and includes antibodies reactive against one or more ofthe at least one analyte.
 60. The apparatus of claim 48, whereinpresence of a visible signal in a test region of the at least onemembrane test strip indicates that an analyte is present above apredetermined threshold concentration in the fluid sample.
 61. A fluidcollection apparatus comprising: an absorbent material, to absorb afluid sample; a compression member operatively associated with theabsorbent material; and a closure member, capable of sealing the openend of a sample receiving member when the fluid collection apparatus isinserted in the sample receiving member.
 62. The apparatus of claim 61,further comprising a lid capable of being affixed to a fluid container,wherein the absorbent material is disposed on the inner side of the lid.63. The apparatus of claim 61, wherein the closure member is capable ofcreating an airtight seal in the open end of the sample receivingmember.
 64. The apparatus of claim 61, wherein the fluid collectionapparatus further comprises a handle removably attached to the uppersurface of the first disk.
 65. The apparatus of claim 61, furthercomprising a saliva-producing substance.
 66. The apparatus of claim 65,wherein the saliva-producing substance is selected from the groupcomprising sugars, salts, acids, and combinations thereof.
 67. Theapparatus of claim 66, wherein the saliva-producing substance isselected from the group consisting of sodium chloride, citric acid, andcombinations thereof.
 68. The apparatus of claim 61, further comprisinga housing surrounding at least part of the absorbent material.
 69. Theapparatus of claim 68, wherein the housing defines at least one openingto allow the fluid sample to enter the absorbent material
 70. Theapparatus of claim 68, wherein the housing further comprises a porousfilter able to strain particulates from the fluid sample.
 71. Theapparatus of claim 68, wherein the housing is slidably coupled to thecompression member.
 72. The apparatus of claim 71, further comprising aspring operatively associated with the absorbent material and orientedwith the direction in which the absorbent material is compressed,whereby compression of the absorbent material results in compression ofthe spring.
 73. The apparatus of claim 72, wherein the absorbentmaterial is compressed between the compression member and the housing.74. The apparatus of claim 73, further comprising means for securing thecompression member relative to the housing in the position in which theabsorbent material is compressed.
 75. The apparatus of claim 74, furthercomprising a lid capable of being affixed to a fluid container, whereinthe absorbent material is disposed on the inner side of the lid.
 76. Anapparatus comprising: a fluid collector to collect the fluid sample andconvey the fluid sample into the sample receiving member, comprising: anabsorbent material, to absorb the fluid sample; a compression memberoperatively associated with the absorbent material; and a closuremember, capable of sealing the open end of the sample receiving memberwhen the fluid collector is inserted in the sample receiving member; asample receiving member, having an opening for receiving a fluid sample;a sample retention member, in fluid communication with the samplereceiving member, to retain a portion of the fluid sample; at least onemembrane test strip, in fluid communication with the sample receivingmember, to indicate the presence or absence of at least one analyte inthe fluid sample; and a fingerprint acquisition pad.
 77. A method oftesting a fluid sample, comprising: collecting a fluid sample in anabsorbent material; conveying the absorbent material into a receivingmember of an apparatus; compressing the absorbent material, whereby: thefluid sample is expelled from the absorbent material into channelswithin the apparatus; the fluid sample encounters at least one membranetest strip within the apparatus that visually indicates the presence orabsence of each of one or more analytes; a portion of the fluid sampleis retained in a sample retention member of the apparatus; contactingthe finger of an individual associated the test with a fingerprintacquisition pad operatively associated with the apparatus, whereby afingerprint is collected.